Atlas FDA

HEB

189 FDA 510(k) clearances · Product code

81 daysmedian time to decision
267 days90th percentile
189clearances measured

FDA profile

Official device name
Tampon, Menstrual, Unscented
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5470
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
FDA definition
An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Adverse events (MAUDE)
2021: 1,403 · 2022: 1,055 · 2023: 702 · 2024: 534 · 2025: 454 · 2026: 252
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Livi Device (K252005)Liviwell, Inc.2026-03-20
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (K253719)Unibeauty (Hubei) Technology Co., Ltd.2025-12-17
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (K252939)Cotton High Tech S.L.2025-10-09
Unscented menstrual three-piece applicator tampon (K252613)Unibeauty (Hubei) Technology Co., Ltd.2025-09-19
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (K251033)Unibeauty (Hubei) Technology Co., Ltd.2025-08-13
SABA Tampons (K242105)Essity Higiene Y Salud Mexico. S.A. DE C.V.2025-04-01
Unscented Tampon (K241064)Shandong Intco Hygiene Products Co., Ltd.2025-01-10
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (K240708)Suzhou Borage Medical Technology Co., Ltd.2024-05-10
TOSAMA Reusable Applicator (K232060)Tosama, D.O.O.2024-04-12
Unscented Menstrual Tampon (K232598)Unibeauty (Hubei) Technology Co., Ltd.2023-12-15
Daye Tampon (K223883)Annes Daye, Ltd.2023-08-18
Organic cotton tampon, Viscose tampon (K231341)Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.2023-08-14
Sequel Tampon with Plastic Applicator (K230419)Tampro, Inc.2023-08-03
U by Kotex® Click® Unscented Menstrual Tampons (K223749)Kimberly-Clark Corporation2023-01-06
Unscented Menstrual Tampon (K222046)Suzhou Borage Medical Technology Co., Ltd.2022-09-30
Tempo Tampon (K212277)Dong-A Pharmaceutical Co., Ltd.2022-04-21
Cohitech Cottonlock Tampons with Reusable Applicator (K220238)Cotton High Tech S.L.2022-02-25
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (K211775)Cotton High Tech S.L.2021-10-22
Cohitech Reusable Tampon Applicator (K212479)Cotton High Tech S.L.2021-10-08
Tempo Natural Tampon (K212272)Dong-A Pharmaceutical Co., Ltd.2021-09-17
Callaly Tampliner (super plus absorbency) (K212304)Calla Lily Personal Care, Ltd.2021-08-19
Every Cycle Reusable Tampon Applicator (K211519)Cycle, LLC2021-08-13
Callaly Tampliner (K211469)Calla Lily Personal Care, Ltd.2021-06-10
Callaly Tampliner (K201003)Calla Lily Personal Care, Ltd.2020-12-07
Youjia Unscented Tampon with Plastic Applicators (K192557)Qingdao Youjia Hygiene Technology Co., Ltd.2020-02-13
Unscented W long plastic and cardboard applicator tampons (K191666)Ontex Bvba2019-12-20
Interlude Rolled Tampons in Plastic Applicator (K191431)Albaad Fem2019-10-07
FEMME Applicator Tampon (K182142)Jiangsu Yoai Technology Co., Ltd.2019-08-28
CottonDay Tampon (K182817)Taebong Co., Ltd.2019-07-22
Rael Tampon (K182814)Rael, Inc.2019-07-15
Unscented Menstrual Tampon (K190218)Qingdao Youjia Hygiene Technology Co., Ltd.2019-05-09
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT (K182813)Cotton High Tech S.L.2019-03-15
Interlude 100% Cotton Tampon (K181911)Albaad Fem2018-11-02
re.t.a Reuseable Tampon Applicator (K180850)Thinx, Inc.2018-08-20
Interlude and private label Unscented 3-piece compact applicator tampon (K173225)Albaad Fem2018-06-15
Playtex Stella Tampons (K180167)Playtex Manufacturing, Inc.2018-05-30
Tosama Biobased Applicator Tube Menstrual Tampon (K172504)Tosama, D.O.O.2018-02-09
U by Kotex Click Unscented Menstrual Tampons (K172118)Kimberly-Clark Corporation2017-10-11
Ontex and other proprietary names (K162746)Ontex Bvba2017-03-03
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl (K161877)First Quality Hygienic, Inc.2016-08-05
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS (K152284)Cotton High Tech S.L.2015-12-04
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency (K151470)First Quality Hygienic, Inc.2015-11-02
Tosama 100% Organic Cotton Menstrual Tampon (K151170)Tosama, D.O.O.2015-07-02
Ontex Unscented Tampons with Colored Plastic Applicators (K142786)Ontex Bvba2015-06-23
Tosama 100% Cotton Menstrual Tampon (K150897)Tosama, D.O.O.2015-04-20
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED (K140077)Albaad , Ltd.2014-09-22
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (K141294)Kimberly-Clark Corp.2014-08-25
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS (K132595)Ontex Bvba2014-04-23
TAMPAX M PLASTIC TAMPONS, UNSCENTED (K133244)The Procter & Gamble Company2014-01-09
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (K131543)Procter & Gamble Co.2013-06-20
VEEDA 100% COTTON MENSTRUAL TAMPON (K130609)Naturalena Brands, Inc.2013-03-21
ONTEX AND OTHER PROPRIETARY NAMES (K122603)Ontex Bvba2012-12-19
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, (K120481)Tosama, D.O.O.2012-07-13
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (K113699)The Procter & Gamble Company2012-01-12
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS (K113036)Kimberly-Clark Corporation2011-11-02
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS (K112635)Kimberly-Clark Corp.2011-10-07
TAMPAX C PLASTIC TAMPONS, UNSCENTED (K110669)The Procter & Gamble Co.2011-06-02
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS (K103311)Kimberly Clark Corporation2010-12-10
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS (K102445)Rostam , Ltd.2010-11-10
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA (K091281)Procter & Gamble Co.2010-06-01
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS (K091749)Kimberly-Clark Corp.2009-12-23
ONTEX TAMPON (UNSCENTED) (K090819)Ontex International NV2009-12-23
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON (K092054)Tosama D.D.2009-07-29
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS (K090071)Rostam , Ltd.2009-05-28
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS (K091084)Cotton High Tech S.L.2009-04-29
COTTONS 100% NATURAL COTTON TAMPONS (K080733)Cottons Pty, Ltd.2009-02-18
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON (K090098)Maxim Hygiene Products, Inc.2009-01-30
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS (K080775)Tosama D.D.2008-09-10
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (K062001)Rostam , Ltd.2006-12-07
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS (K062638)Procter & Gamble Co.2006-11-22
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) (K061486)Procter & Gamble Co.2006-08-01
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) (K051290)Procter & Gamble Co.2005-12-27
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (K050660)First Quality Hygienic, Inc.2005-05-12
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) (K040999)Procter & Gamble Co.2004-07-09
PH BUFFERING PLASTIC APPLICATOR TAMPON (K030474)Rostam , Ltd.2004-05-28
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) (K032636)Playtex Products, Inc.2003-11-14
FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS (K031067)First Quality Hygienic, Inc.2003-07-14
O.B. TAMPONS (K023789)Mcneil-Ppc, Inc.2002-12-06
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES (K023479)First Quality Hygienic, Inc.2002-11-26
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (K020535)Rostam , Ltd.2002-05-09
VIPON TAMPON (K992493)Another Way Products, LLC2000-11-06
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR (K002096)Procter & Gamble Co.2000-09-08
TAMPONS (K001641)Rostam , Ltd.2000-08-03
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS (K993794)Playtime Products, Inc.2000-02-07
O.B. TAMPON (K990536)Personal Products Co.1999-08-31
O.B. APPLICATOR TAMPONS, O.B. TAMPONS (K991118)Personal Products Co.1999-06-29
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON (K983478)Organic Essentials1998-11-09
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (K983381)Paragon Trade Brands, Inc.1998-10-19
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (K981953)Paragon Trade Brands, Inc.1998-08-18
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 (K981760)Playtime Products, Inc.1998-07-22
PLAYTEX TAMPONS #03498 (K980478)Playtex, Inc.1998-04-03
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (K974629)Personal Products Co.1998-02-10
O.B. APPLICATOR TAMPONS (K970954)Personal Products Co.1997-06-10
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS (K971174)Playtex, Inc.1997-05-21
FEMTEX 100% COTTON TAMPONS (K971228)Regu-Tech Assoc., Inc.1997-04-09
HARMONIES MENSTRUAL TAMPON (K970108)Ecoprogress Intl.1997-04-03
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS (K970232)Regu-Tech Assoc., Inc.1997-03-21
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON (K965064)Rostam , Ltd.1997-02-20
FEMTEX GENTLE TOUCH TAMPONS (K963034)First Quality Hygienic, Inc.1996-11-01
FREE CHOICE (K963032)First Quality Hygienic, Inc.1996-10-11
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